YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 320 drug applications between 4 April 2025 and 10 April 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 96, covering 69 drug names.
2025/04/04 – 2025/04/10
- New acceptances this week
- 320
- Drugs with new generic filings (by drug name, de-duplicated)
- 69
- Accepted this week, now under review
- 30
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
320filings, 96 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 145 |
| Generic | 96 |
| New drug | 47 |
| Import | 22 |
| Unspecified | 5 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 214 |
| TCM | 67 |
| Therapeutic biologic | 36 |
| Prophylactic biologic | 3 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
69 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 5 | 3 | 60 |
| 2 | Dopamine Hydrochloride Injection | 4 | 2 | 3 |
| 3 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 4 | Oxacillin Sodium for Injection | 3 | 1 | 13 |
| 5 | Rosuvastatin Calcium and Ezetimibe Tablets (I) | 2 | 2 | 5 |
| 6 | Ilaprazole Enteric-coated Tablets | 2 | 2 | 26 |
| 7 | Iron Proteinsuccinylate Oral Solution | 2 | 2 | 26 |
| 8 | Dapagliflozin and Metformin Hydrochloride Sustained-release Tablets (Ⅰ) | 2 | 2 | 5 |
| 9 | Tadalafil Tablets | 2 | 1 | 23 |
| 10 | Empagliflozin Tablets | 2 | 1 | 18 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
196 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guo Yao Group Beijing Hua Miao Pharma Co., Ltd. romanized | 11 | 10 | 0 |
| 2 | Guangzhou Shi Lian Rui Pharmaceutical Co., Ltd. romanized | 10 | 10 | 0 |
| 3 | AstraZeneca AB | 6 | 3 | 0 |
| 4 | Bayer Inc. | 6 | 1 | 0 |
| 5 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 7 | Boehringer Ingelheim International GmbH | 5 | 3 | 0 |
| 8 | Merck Healthcare KGaA | 5 | 3 | 0 |
| 9 | Shen Wei Pharma Group Co., Ltd. romanized | 4 | 3 | 0 |
| 10 | Takeda Pharmaceuticals U.S.A. Inc. | 4 | 2 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
101 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/04/10Generic · Class 3 | Bumetanide InjectionCYHS2501389 | Hefei Yuan Feng Shun Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Bai Yu Pharmaceutical Co., Ltd. romanized |
| 2025/04/10Generic · Class 3 | Celecoxib TabletsCYHS2501388 | Kunming Yuan Rui Pharmaceutical Co., Ltd. romanized |
| 2025/04/10Generic · Class 3 | Minodronic acid TabletsCYHS2501386 | Anhui Bo Nuo Mei Ke Biopharmaceuticals Co., Ltd. romanized; Anhui Jin Tai Yang Sheng Hua Pharma Co., Ltd. romanized |
| 2025/04/10Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2501384 | Guangdong Nan Guo Pharma Co., Ltd. romanized |
| 2025/04/10Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2501383 | Guangdong Nan Guo Pharma Co., Ltd. romanized |
| 2025/04/10Generic · Class 3 | Ferrous Succinate TabletsCYHS2501379 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2025/04/10New drug · Class 1.1 | 健脾解毒丸 · No verified English nameCXZL2500021 | Xinjiang Wei Wu Er Zi Zhi Qu Zhong Yi Hospital romanized |
| 2025/04/10New drug · Class 1 | LNF2102注射液 · No verified English nameCXSL2500287 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2025/04/10New drug · Class 1 | SCG101-V自体T细胞注射液 · No verified English nameCXSL2500286 | Xing Yuan De Biopharmaceuticals (Shanghai) Co., Ltd. romanized; Xing Han De (Shanghai) Biopharmaceuticals Co., Ltd. romanized |
| 2025/04/10New drug · Class 1 | 注射用QLS32015 · No verified English nameCXSL2500285 | Qilu Pharmaceutical Co., Ltd. |
| 2025/04/10New drug · Class 2.2 | QL2109注射液 · No verified English nameCXSL2500284 | Qilu Pharmaceutical Co., Ltd. |
| 2025/04/10New drug · Class 1.4 | 四价肠道病毒灭活疫苗(Vero细胞) · No verified English nameCXSL2500283 | Guo Yao Zhong Sheng Bio Technology Research Institute Co., Ltd. romanized |
| 2025/04/10New drug · Class 1.3 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2500282 | Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized |
| 2025/04/10New drug · Class 1 | MSLN-CAR-T细胞注射液 · No verified English nameCXSL2500281 | Shanghai Yi Hao Bio Technology Co., Ltd. romanized |
| 2025/04/10New drug · Class 1 | DZD6008片 · No verified English nameCXHL2500376 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2025/04/10New drug · Class 1 | DZD6008片 · No verified English nameCXHL2500375 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2025/04/10New drug · Class 2.4 | 舒沃替尼片 · No verified English nameCXHL2500374 | Di Zhe (Jiangsu) Pharmaceuticals Co., Ltd. romanized |
| 2025/04/10New drug · Class 1 | 注射用TFX05-01 · No verified English nameCXHL2500373 | Zhejiang Yang Li Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/04/10New drug · Class 1 | 注射用SBK009 · No verified English nameCXHL2500372 | Chengdu Shi Bei Kang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/04/10New drug · Class 1 | TQH3906胶囊 · No verified English nameCXHL2500371 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/04/10New drug · Class 1 | TQH3906胶囊 · No verified English nameCXHL2500370 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2025/04/10New drug · Class 1 | VS-2218固体分散体片 · No verified English nameCXHL2500369 | Wei Jiu Bio Technology (Suzhou) Co., Ltd. romanized |
| 2025/04/10New drug · Class 1 | VS-2218固体分散体片 · No verified English nameCXHL2500368 | Wei Jiu Bio Technology (Suzhou) Co., Ltd. romanized |
| 2025/04/09Import · Class 3.1 | 注射用阿帕达酶α · No verified English nameJXSS2500044 | Takeda Pharmaceuticals U.S.A. Inc.; Takeda Manufacturing Austria AG |
| 2025/04/09Import · Class 3.1 | 注射用阿帕达酶α · No verified English nameJXSS2500043 | Takeda Pharmaceuticals U.S.A. Inc.; Takeda Manufacturing Austria AG |
| 2025/04/09Import · Class 1 | VAY736注射液 · No verified English nameJXSL2500057 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/04/09Import · Class 1 | MEDI5752 · No verified English nameJXSL2500056 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/04/09Import · Class 1 | ABBV-324注射用粉末 · No verified English nameJXSL2500055 | AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd. |
| 2025/04/09Import · Class 1 | Casdatifan 片 · No verified English nameJXHL2500076 | Arcus Biosciences Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd. |
| 2025/04/09Import · Class 1 | BI1815368 片 · No verified English nameJXHL2500075 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (Cnina) Investment Co. Ltd. |
71 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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